Comprehensive drug development and approval package data combined with predictive analytics support translational research, reduce animal testing and ensure drug safety

London, United Kingdom--(Newsfile Corp. - October 10, 2023) - Elsevier, a global leader in information and data analytics, has launched the new PharmaPendium, sharpening the translational view of a platform that combines extensive preclinical and clinical data, including complete Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval packages, with predictive tools to accelerate drug development. PharmaPendium enables companies to make faster, more informed decisions about what drug candidates to advance. Pharma professionals and researchers can use the tool to benchmark against competitors, prioritize safety and efficacy, and develop effective strategies for regulatory submissions. The depth and reliability of the platform's data means PharmaPendium is already trusted by the FDA, Pharmaceuticals and Medical Devices Agency (PMDA) and the top 20 global pharma companies.

"Translation of preclinical research findings to humans in an efficient but safe way is one of the greatest challenges facing drug developers. We designed the new PharmaPendium to solve this. The platform leverages Elsevier's expertise in curating scientific data and presents it in an intuitive and meaningful way for pharma professionals," adds Olivier Barberan, Director of Translational Medicine Solutions at Elsevier. "This improved access to highly relevant data plus predictive tools enhances regulatory success, safeguarding the massive investments of pharma companies."

PharmaPendium's advanced predictive tools include the Drug-Drug Interaction Risk Calculator (DDIRC) and Safety Margin Tool. These solutions empower researchers to accurately predict harmful drug-drug interactions and off-target related clinical adverse events, and to optimize nonclinical studies and reduce animal testing. They were co-designed to meet industry needs and align with regulatory guidance. Elsevier collaborated with Novartis on the Safety Margin Tool, and with Boehringer Ingelheim, Eli Lilly and Company, Pierre Fabre, Sanofi, Servier and others on the DDIRC.

Today, 93% of drugs entering clinical trials fail to secure regulatory approval. Better understanding of first-in-human dose selection, optimal study endpoints and mitigating adverse events improves regulatory success. Yet translation from preclinical studies to post-market data analysis is time-consuming and expensive. The new PharmaPendium helps overcome these challenges with:

• Enhanced visualization tools to more easily gain insights from vast quantities of data
• Intelligent autocomplete to increase discoverability and identify important concepts
• Improved search results interface to quickly access key data, such as drug metabolism and pharmacokinetics (DMPK), efficacy and chemistry, extracted from leading data sources, including:
  • Complete FDA and EMA approval packages and FDA advisory committee documents
  • 19 million reports from the FDA Adverse Event Reporting System (FAERS)
  • DESI (Drug Efficacy Study Implementation) documents, Meyler's 16th Edition, Mosby's Drug Consult™️ and scientific articles

PharmaPendium's high-quality datasets are machine readable and available for off-platform use, allowing companies to embed data into their workflows and employ predictive and scenario modelling. Customers can also access support from Elsevier's team of domain and data science experts for their data projects.

Learn more about PharmaPendium.

About Elsevier

As a global leader in information and analytics, Elsevier helps researchers and healthcare professionals advance science and improve health outcomes for the benefit of society. We do this by facilitating insights and critical decision-making for customers across the global research and health ecosystems.

In everything we publish, we uphold the highest standards of quality and integrity. We bring that same rigor to our information analytics solutions for researchers, academic leaders, funders, R&D-intensive corporations, doctors, and nurses.

Elsevier employs 9,000 people worldwide, including over 2,500 technologists. We have supported the work of our research and health partners for more than 140 years. Growing from our roots in publishing, we offer knowledge and valuable analytics that help our users make breakthroughs and drive societal progress. Digital solutions such as ScienceDirect, Scopus, SciVal, ClinicalKey and Sherpath support strategic research management, R&D performance, clinical decision support, and health education. Researchers and healthcare professionals rely on over 2,800 journals, including The Lancet and Cell; 46,000+ eBook titles; and iconic reference works, such as Gray's Anatomy. With the Elsevier Foundation and our external Inclusion & Diversity Advisory Board, we work in partnership with diverse stakeholders to advance inclusion and diversity in science, research and healthcare in developing countries and around the world.

Elsevier is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers.

Media contact
Terri Mueller
+1 908 323-9180
t.mueller@elsevier.com

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